# FDA 483 - GRUNENTHAL GMBH - July 10, 2026

Source: https://www.keypedia.com/records/483/grunenthal-gmbh/c760db76-3579-46aa-bfd1-20fb53151ff0

> FDA 483 for GRUNENTHAL GMBH on July 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GRUNENTHAL GMBH
- Inspection Date: 2026-07-10
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: GRUNENTHAL GMBH, a bulk drug manufacturer in Germany, was cited during an FDA inspection for a quality control deficiency. The firm's Finished Bulk Product laboratory lacked a formal "rounding" document, which resulted in inconsistent analytical results for product purity. This issue highlights a potential weakness in their laboratory data integrity and procedural controls.

## Related Officers

- [RICHARD H. PENTA](https://www.keypedia.com/people/richard-h-penta/2f909dea-0bfb-44df-8231-a634b285269f)

Company: https://www.keypedia.com/companies/grunenthal-gmbh/55ddeafc-e5dc-4cf1-a7fc-49b79f4c27d5

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c